Type 2 DiabetesSONICNCT04114903
Exploring the Anti-inflammatory Properties of Cannabis and Their Relevance to Insulin Sensitivity
An observational study of Type 2 Diabetes and Obesity, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Type 2 Diabetes, Obesity, Cannabis Use
- What is being tested?
- Study A: Single use of cannabis flower product and Study B: Ad libitum cannabis use for four weeks or no cannabis use
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2019to 1 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Adult
Study population: Community Sample
Who may be able to join
- Able to provide informed consent
- Cannabis users in Study A must have smoked or vaped cannabis at least once since January 1st 2014 with no negative effects but NOT used in the past three months
- Cannabis users in Study B must have been a regular (at least weekly) user for at least a year
- Non-users in Study B cannot have used any cannabis in the previous year
- Weight stable (<5 pound fluctuation in the past six months)
- Planning to remain in the Boulder-Denver area for the next month
- Fasting blood glucose greater than or equal to 55 mg/dl and less than or equal to 126 mg/dl
- Cannabis users in Study A must endorse knowledge of the procedure(s) for smoking or vaping cannabis
Who cannot join
- Known auto-immune disease
- Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
- Daily tobacco (cigarette, E-cigs, smokeless) user, given the impact of tobacco smoking on insulin function
- Blood alcohol level greater than 0 at screening
- Current use of medications for glucose lowering, immunosuppression, or anti-inflammation
- Acute illness
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- Current use of psychotropic medications
- Current diagnosis of diabetes
- Heavy drinking as defined by an Alcohol Use Disorders Test (AUDIT)
- Females can not be pregnant or trying to become pregnant
- Females can not be nursing mothers
- Have donated blood in the 8 weeks before the study or intend to donate blood in the 8 weeks after the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovation and Creativity
Boulder, Colorado, 80301
About this study
This study tests the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects. Blood levels of THC and CBD, inflammatory biomarkers, and insulin resistance will be measured in both studies.
Read the detailed description
According to the National Institute of Diabetes and Digestive and Kidney Diseases, over 30 million people in the US have diabetes, and just over 84 million people have pre-diabetes. Concurrently, 30 states and the District of Columbia have legalized cannabis for medical and/or recreational use and over the past decade, cannabis use among adults has more than doubled.
Public perception and some scientific data suggest that cannabis causes acute over-eating, creating concern that public and legal acceptance of cannabis use will worsen the obesity epidemic in the United States, where more than two-thirds of US adults (68.8%) are currently overweight or obese. Paradoxically, cross sectional data demonstrate associations between chronic cannabis use and lower body mass index (BMI), prevalence of obesity, insulin resistance, waist circumference, and actual rates of type 2 diabetes despite data supporting higher caloric intake acutely.
This study examines the effects of cannabinoid levels in blood on inflammation and insulin sensitivity both acutely and chronically in individuals across the weight spectrum. To that end, the study employs two observational designs: 1) A study of acute effects with intermittent cannabis users and 2) A study in which current cannabis users will select one of three cannabis strains for four weeks and are compared to a matched control group who do not use cannabis to study chronic effects.
- Conditions
- Type 2 Diabetes, Obesity, Cannabis Use, Insulin Sensitivity
- Being tested
- Study A: Single use of cannabis flower product, Study B: Ad libitum cannabis use for four weeks or no cannabis use
- Keywords
- Diabetes, Obesity, Cannabis, Insulin Sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance, Diabetes Mellitus, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study A: Single use of cannabis flower productOther
Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0% CBD), or 3) THC+CBD (~7% THC/7% CBD).
Study B: Ad libitum cannabis use for four weeks or no cannabis useOther
Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (~14% CBD/0% THC), 2) THC (~14% THC/0% CBD), or 3) THC+CBD (~7% THC/7% CBD).
| Study group | Role | What they receive |
|---|---|---|
| Study A | Adults balanced across the weight spectrum who have tried cannabis at least once with no negative reaction but are not regular users. Receives: Other: Study A: Single use of cannabis flower product | |
| Study B | Sample of current cannabis users and non-users balanced across the weight spectrum who are matched on age, gender, BMI and physical activity. Receives: Other: Study B: Ad libitum cannabis use for four weeks or no cannabis use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of Inflammation
Change in Circulating Levels of Cytokines (TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4). Results are reported as a composite score of TNF-α, IL-6, IL-1β, IL-12, IFNG, and IL-4
Measured: Study A: Difference between cytokines at baseline and cytokines one week later after acute use of cannabis product. Study B: Change from baseline to four weeks
Change in Matsuda Index of Insulin Sensitivity
Calculation of Insulin Sensitivity using changes in fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes after ingestion of 75 grams oral glucose during oral glucose tolerance test (OGTT). Values across the timepoints were combined to create a Matsuda Index score as follows: 10000/sqrt ((FPG X FPI) X (Mean OGTT glucose concentration X Mean OGTT insulin concentration)).
Higher scores mean higher sensitive to insulin and that your body more efficiently clears glucose from your bloodstream, thus higher scores are better.
Measured: Study A: Baseline versus after acute use one week later of cannabis product. Study B: The two tests will be separated by four weeks
Change in Plasma Glucose
Change in glucose over time after ingestion of 75 grams oral glucose measured during during oral glucose tolerance test (OGTT). Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.
Measured: Study A: Baseline versus one week later after acute use of cannabis product. Study B: The two tests will be separated by four weeks
Change in Plasma Insulin
Change in insulin over time after ingestion of 75 grams oral glucose measured during OGTT. Measurements are collected on venous blood samples at 0, 30, 60, 90, and 120 minutes and averaged across these timepoints for a mean score.
Measured: Study A: Baseline versus one week later after acute use of cannabis product. Study B: Baseline versus four weeks later
Secondary outcomes (10)
Stanford Seven-Day Physical Activity Recall (PAR)
Interviewer administered assessment of number of minutes of moderate to vigorous physical activity over the previous seven days. Scores are reported as total minutes in the last week summed across moderate, hard, and very hard activity levels.
Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Sleep Quality
Pittsburgh Sleep Quality Index: Measurement of the quality and patterns of sleep from poor to good measuring seven domains (e.g., latency, duration, disturbances) over the last 2 weeks. Participants' scores are reported as a global score of the summed seven component scores together ranging from 0 to 21, where higher scores indicate worse sleep and a global score of 5 or above indicates poor sleep quality.
Measured: Study A: Baseline only Study B: Baseline to four weeks following baseline
Marijuana Consumption Questionnaire
Times per day of cannabis flower use from 0 to 6. Includes all participants in Study A and only cannabis users in Study B.
Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline
Marijuana Dependence Scale
This is a self-report scale based on DSM-5 criteria to assess dependence and other problems related to the use of cannabis. Scores are reported as a sum across the 11 items with yes/no options, ranging from 0 to 11, with higher scores indicating more dependence symptoms. Includes all participants in Study A and only cannabis users in Study B.
Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline
Marijuana Withdrawal Checklist
A 15-item scale used to collect information on withdrawal symptoms that participants may be experiencing due to the lack of use of marijuana. Options range from 0 (none) to 3 (severe) for each question and are summed to create a final score ranging from 0 to 45. Includes all participants in Study A and only cannabis users in Study B.
Measured: Study A: Assessed at follow-up, one week following baseline. Study B: Assessed at follow-up, four weeks following baseline.
The Alcohol Use Disorder Identification Test (AUDIT)
Standardized assessment of the extent of alcohol use and problems related to alcohol use. Scores are summed and range from 0 to 40 with higher scores indicating more hazardous alcohol use.
Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline
Timeline Follow-Back of Substance Use
Calendar-based assessment of daily substance use for the 30 days prior to the baseline session for both studies. The average days of smoked cannabis use in the last 30 days are reported.
Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline
SF-12 Health Survey
The SF-12 Health Survey is a 12-item questionnaire used to assess general health and well-being and includes domains of physical functioning, role-physical, pain, general health, vitality, social functioning, role-emotional and mental health. Only the mental component was analyzed. Scores are calculated using a weighted algorithm with scores ranging from 0 to 100; scores greater than 50 meaning better than average health and scores worse than 50 meaning worse than average health.
Measured: Study A: Baseline only. Study B: Baseline and four weeks following baseline
Nutrition Data System for Research 24-Hour Dietary Recall
Interviewer administered recall measure developed by the University of Minnesota Nutrition Coordinating Center (NCC), that facilitates the standardized collection of 24-hour dietary recall data. Healthy Eating Index (HEI) total scores are reported for each participant, which is a measure of healthy eating on a scale of 0 (poor eating) to 100 (very healthy eating). Scores above 80 indicate a good diet, and scores below 80 indicate a diet in need of improvement.
Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Stanford Leisure-Time Activity Categorical Item (L-Cat)
Self-report measure of a single item comprising six descriptive categories ranging from inactive (1) to very active (6).
Measured: Study A: Baseline and one week following baseline Study B: Baseline and four weeks following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start8 Nov 2019
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Angela Bryan, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114903
- Sponsor's protocol ID
- 1R01DA050515
- Acronym
- SONIC
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2019
- Last updated
- 6 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryan AD, Skrzynski CJ, Yang J, Chrystal KA, Bidwell LC, Hutchison KE, Perreault L. Inhaling high THC cannabis acutely increases inflammation but not insulin sensitivity: a quasi-randomized trial. Sci Rep. 2026 Jul 16. doi: 10.1038/s41598-026-62837-0. Online ahead of print.
PubMed 42463843Skrzynski CJ, Bryan AD, Schmiege SJ. Quasi-randomization to Cannabinoid Condition in Studies of US Legal Market Cannabis: Characteristics of Accepters Versus Decliners of Condition Assignment. Prev Sci. 2026 Mar;27(3):441-450. doi: 10.1007/s11121-026-01893-4. Epub 2026 Mar 13.
PubMed 41820717